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Study on Antibiotic Treatment for Uncomplicated Acute Appendicitis Using Levofloxacin, Ertapenem, and Moxifloxacin in Adult Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of uncomplicated acute appendicitis, a condition where the appendix becomes inflamed but does not have severe complications. The study aims to compare two different approaches to treating this condition using antibiotics. One approach involves taking antibiotics by mouth, known as oral antibiotics, while the other involves starting with antibiotics given through a vein, known as intravenous antibiotics, followed by oral antibiotics.

The antibiotics being studied in this trial include Levofloxacin, Ertapenem, Moxifloxacin, and Metronidazole. Levofloxacin and Moxifloxacin are taken as tablets, while Ertapenem is given as a solution through an infusion, which is a method of delivering medication directly into the bloodstream. Metronidazole is also taken as a tablet. These medications are all antimicrobial agents, which means they are used to treat infections caused by bacteria.

The purpose of the study is to determine if oral antibiotic treatment alone is as effective as the combination of intravenous and oral antibiotics in treating uncomplicated acute appendicitis. Participants in the study will receive one of these treatments, and their progress will be monitored to see if the appendicitis resolves without the need for surgery and does not return within a year. The study will also look at other factors such as any complications after treatment, the length of hospital stay, and the overall quality of life of the participants during the follow-up period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria: age between 18 and 60 years, and a diagnosis of uncomplicated acute appendicitis confirmed by a CT scan.

    The CT scan must show an appendiceal diameter over 6 mm with a thickened and enhancing wall, periappendiceal edema, or minor fluid collection, without signs of complicated appendicitis.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to one of two treatment groups: oral antibiotic monotherapy or a combination of intravenous and oral antibiotics.

  3. Step 3

    Oral antibiotic monotherapy

    Participants in this group receive levofloxacin and metronidazole orally.

    The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Intravenous and oral antibiotic therapy

    Participants in this group initially receive ertapenem through an intravenous infusion.

    After the intravenous treatment, participants switch to oral antibiotics, specifically moxifloxacin and metronidazole.

    The duration and dosage are specified in the study protocol.

  5. Step 5

    Follow-up and monitoring

    Participants are monitored for treatment success, defined as the resolution of appendicitis without surgery and no recurrence within one year.

    Follow-up includes assessing any complications, recurrence of appendicitis, hospital stay duration, pain levels, quality of life, sick leave length, and treatment costs.

  6. Step 6

    Completion of the study

    The study concludes with a one-year follow-up to evaluate the primary endpoint of treatment success.

    Secondary endpoints such as complications, recurrence, and quality of life are also assessed.

Who can join the trial?

7 criteria

  • Must be between the ages of 18 and 60 years old.
  • Must have a diagnosis of **uncomplicated acute appendicitis**. This means the appendix is swollen and inflamed but not severely damaged or ruptured.
  • The diagnosis must be confirmed by a **CT scan**. A CT scan is a special type of X-ray that gives detailed pictures of the inside of the body.
  • The CT scan must show that the appendix is larger than 6 millimeters, has a thickened wall, and there is some swelling or minor fluid around it.
  • There should be no signs of **complicated appendicitis**, which would mean more severe issues like a burst appendix.
  • Both men and women can participate.
  • Participants should not be part of a vulnerable population, meaning they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who cannot join the trial?

3 criteria

  • Patients with a condition other than uncomplicated acute appendicitis cannot participate. This means if the appendicitis is more severe or has complications, they are not eligible.
  • Patients who are younger than 18 years old cannot participate. The study is only for adults.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or have certain disabilities, are not eligible.
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Investigated drugs

  • Amoxicillin

    is an antibiotic used to treat various bacterial infections. In this trial, it is used to treat uncomplicated acute appendicitis. It works by stopping the growth of bacteria.

  • Clavulanic Acid

    is often combined with amoxicillin to enhance its effectiveness. It helps prevent bacteria from becoming resistant to amoxicillin, ensuring the treatment remains effective.

  • Metronidazole

    is another antibiotic used in this trial. It is effective against certain types of bacteria and parasites. In the context of appendicitis, it helps eliminate bacteria that may not be targeted by other antibiotics.

  • Ciprofloxacin

    is an antibiotic that treats a wide range of bacterial infections. It is used in this trial to help manage uncomplicated acute appendicitis by killing bacteria or preventing their growth.

What is already known about the treatment

  • Amoxicillin

    This medication is administered orally in the form of tablets or liquid suspension. It is currently being studied in clinical trials for its effectiveness in treating uncomplicated acute appendicitis. The main therapeutic indication is to treat bacterial infections, including those affecting the appendix. Amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified as a penicillin-type antibiotic.

  • Ceftriaxone

    This medication is administered intravenously, typically in a hospital setting. It is being evaluated in clinical trials for its use in treating uncomplicated acute appendicitis. The primary therapeutic indication is to treat severe bacterial infections. Ceftriaxone works by interfering with the formation of the bacterial cell wall, causing the bacteria to die. It belongs to the class of cephalosporin antibiotics.

Investigated diseases

Uncomplicated Acute Appendicitis – This condition involves inflammation of the appendix, a small pouch attached to the large intestine. It is termed "uncomplicated" when the inflammation has not led to rupture or abscess formation. Symptoms typically include sudden pain beginning around the navel and often shifting to the lower right abdomen, along with nausea, vomiting, and fever. The pain may increase with movement, coughing, or sneezing. If untreated, the inflammation can worsen, but in uncomplicated cases, it remains localized. The progression is usually rapid, requiring timely medical attention to prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518984-36-00Estimated enrolment599 patientsSponsorTurku University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).